12-25 Nitrosamlnes—compounds derived from the reaction of nitrite with amines—are carcinogenic in numerous species of laboratory animals and mutagenic in several experimental systems. Nitrate appears to be neither carcinogenic nor mutagenic, whereas nitrite is probably not directly carcinogenic, but it is mutagenic in microbial systems. There is some inconclusive epidemiological evidence that nitrate, nitrite, and N-nitroso compounds play a role in the development of gastric and esophageal cancer. Many of the naturally occurring substances discussed in this chapter have been found to be carcinogenic in laboratory animals and/ or mutagenic in bacterial and other systems, thereby posing a potential risk of cancer in humans. However, there have been no pertinent epi- demiological studies concerning their impact on -humans except for those on aflatoxins and those on nitrate, nitrite, and N-nitroso compounds. The compounds thus far shown to be carcinogenic in animals have been reported to occur in the average U.S. diet in small amounts; however, there is no evidence that any of these substances individually makes a major contribution to the total risk of cancer in the United States. This lack of sufficient data should not be interpreted as an indication that these or other compounds subsequently found to be carcinogenic do not present a hazard. Further investigations are necessary. Efforts should be made to minimize or avoid the exposure of humans to compounds that are carcinogenic or mutagenic in experimental systems.